Control means the possession of the ability to grant a license without violating the terms of any agreement or other arrangement with any Third Party.
Damages means any and all costs, losses, claims, demands for payment, government enforcement actions, liabilities, fines, penalties, expenses, court costs and reasonable fees and disbursements of counsel, consultants and expert witnesses incurred by a Party hereto or its Affiliates (including any court-imposed interest in connection therewith), each as a result of any claim, demand, action, investigation or other proceeding by any Third Party.
Effective Date has the meaning set forth in the first paragraph hereof.
FDA means the United States Food and Drug Administration, or any successor federal agency having responsibility over regulatory approval. FDA shall also be deemed to include the applicable governmental or regulatory authority having jurisdiction over Licensed Products in any particular country or region in the Territory (for example, the European Medicines Evaluation Agency for the European Union).
Field means the diagnosis, treatment, prevention, mitigation and cure of any and all human diseases and disorders.
Financing means the next sale after the Effective Date of shares of Lumenas capital stock in one transaction or a series of related transactions which is a bona fide financing transaction with net proceeds to Lumena (after giving effect to applicable fees and costs) of not less than [
] U.S. dollars [
] and up to [
] U.S. dollars [
] and in which the proceeds to be received by Lumena are principally from Accredited Investors who are venture capital, private equity, institutional, corporate or similar investors, on terms and conditions negotiated among Lumena and such investors.
First Commercial Sale means the first arms length sale of a Licensed Product in a country by Lumena or its Affiliate or its sublicensee to a Third Party that is not an Affiliate of the selling party following Regulatory Approval in such country.
Fully-Diluted Shares has the meaning set forth in Section 3.3.
GAAP means United States Generally Accepted Accounting Principles, consistently applied.
Inventions has the meaning set forth in Section 5.1.
Investors has the meaning set forth in Section 3.3.
Licensed Know-How means all information, documentation and data owned or Controlled by Pfizer which is listed in Section 1 of Exhibit A of this Agreement, as such Exhibit may be amended from time to time upon the mutual written agreement of the Parties.
Licensed Product means any pharmaceutical product, in any form or formulation,that contains or comprises the Compound, alone or in combination with one or more other active ingredients.